006 Estriol Cream

006 Estriol Cream
SPL v1
SPL
SPL Set ID 44de9eb4-080e-bfbc-e063-6394a90ac0ea
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Estriol (0.2 g)
Inactive Ingredients
Allantoin Carbomer Lecithin, Sunflower Estradiol Isopropyl Palmitate Glycerin Sodium Bicarbonate Coconut Oil Dimethyl Sulfone Tricaprin Stearic Acid Olive Oil Water Aloe Vera Leaf Shea Butter Peach Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Estradiol 0.2%


Medication Information

Warnings and Precautions

Warnings

For external use only. Do not use if pregnant, nursing. or trying to conceive. Avoid contact with eyes. If contact occurs,rinse thoroughly with water. If irritation or rash develops, discontinue use and consult a healthcare provider.Keep out of reachof children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications and Usage

Uses

Helps support hormonal balance. May help ease symptoms associated with menopause.

Dosage and Administration

Directions

Massage into the inner arm, thighs,ochest,or apply to the inner forearm and rub arms together until absorbed Apply two pumps in the morning and two in the afternoon or evening, or as directed by a healthcare provider.

Description

Estradiol 0.2%

Section 44425-7

CoreStorage

Conditions

Cool. Dry Environment: The product should be stored at room temperature (ideally between 15-25℃ / 59-77°F). in a dry place.and away from direct sunlight.High temperatures and direct sunlight can accelerate the oxidation and breakdown of active ingredients. leading to reduced effectiveness or changes in consistency (e.g.. the cream may become thinner or separate).

Other information

Store in a cool, dry place. Do not use if seal is broken or missing.

"These slalemenis have not been evalualed by the Food and Drug Adiministration, This product is not intended to diagnose, treat, cure. or prevent any disease."

Section 50565-1

Keep out of reachof children.

Section 50566-9

If irritation or rash develops, discontinue use and consult a healthcare provider.

Section 50567-7

Avoid contact with eyes. If contact occurs,rinse thoroughly with water.

Section 50570-1

Do not use if pregnant, nursing. or trying to conceive.

Section 51727-6

Inactive ingredients

Purified Water, Peach extract.Vegetable Glycerin, Aloe Vera Leaf Gel,Caprylic/Capric Triglyceride.Stearic Acid, Micronized Estriol USP Micronized Estradiol USP Olive Oil.Coconut Oil. Shea Butter, Sunflower Lecithin.Methylsulfonyimethane (MSM). Stearyl Alcohol, Isopropyl Palmitate.Allantoin,Carbomer, Sodium Bicarbonate.

Section 51945-4

Section 55105-1

Hormone suppor

Section 55106-9

Estradiol 0.2%


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps support hormonal balance. May help ease symptoms associated with menopause.

Dosage and Administration (34068-7)

Directions

Massage into the inner arm, thighs,ochest,or apply to the inner forearm and rub arms together until absorbed Apply two pumps in the morning and two in the afternoon or evening, or as directed by a healthcare provider.

Warnings and Precautions (34071-1)

Warnings

For external use only. Do not use if pregnant, nursing. or trying to conceive. Avoid contact with eyes. If contact occurs,rinse thoroughly with water. If irritation or rash develops, discontinue use and consult a healthcare provider.Keep out of reachof children. If swallowed, get medical help or contact a Poison Control Center immediately.

Section 44425-7 (44425-7)

CoreStorage

Conditions

Cool. Dry Environment: The product should be stored at room temperature (ideally between 15-25℃ / 59-77°F). in a dry place.and away from direct sunlight.High temperatures and direct sunlight can accelerate the oxidation and breakdown of active ingredients. leading to reduced effectiveness or changes in consistency (e.g.. the cream may become thinner or separate).

Other information

Store in a cool, dry place. Do not use if seal is broken or missing.

"These slalemenis have not been evalualed by the Food and Drug Adiministration, This product is not intended to diagnose, treat, cure. or prevent any disease."

Section 50565-1 (50565-1)

Keep out of reachof children.

Section 50566-9 (50566-9)

If irritation or rash develops, discontinue use and consult a healthcare provider.

Section 50567-7 (50567-7)

Avoid contact with eyes. If contact occurs,rinse thoroughly with water.

Section 50570-1 (50570-1)

Do not use if pregnant, nursing. or trying to conceive.

Section 51727-6 (51727-6)

Inactive ingredients

Purified Water, Peach extract.Vegetable Glycerin, Aloe Vera Leaf Gel,Caprylic/Capric Triglyceride.Stearic Acid, Micronized Estriol USP Micronized Estradiol USP Olive Oil.Coconut Oil. Shea Butter, Sunflower Lecithin.Methylsulfonyimethane (MSM). Stearyl Alcohol, Isopropyl Palmitate.Allantoin,Carbomer, Sodium Bicarbonate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hormone suppor

Section 55106-9 (55106-9)

Estradiol 0.2%


Advanced Ingredient Data


Raw Label Data

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